FDA Approves New Drug for Advanced Bladder Cancer

On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma. The immune-oncology drug is intended for use in patients “who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.”

In addition to the approval of Imfinzi, the FDA also approved the VENTANA PD-L1 (SP263) Assay. The product is manufactured by Ventana Medical Systems, Inc., and was approved “as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.”

According to the FDA’s announcement, Imfinzi’s “approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks. Confirmed objective response rate (ORR) as assessed by blinded independent central review per RECIST 1.1, was 17.0% (95% CI: 11.9, 23.3). At the data cutoff for the ORR analysis, median response duration was not reached (range: 0.9+ to 19.9+ months). ORR was also analyzed by PD-L1 expression status as measured by VENTANA PD-L1 (SP263) Assay. In the 182 patients, the confirmed ORR was 26.3% (95% CI: 17.8, 36.4) in 95 patients with a high PD-L1 score and 4.1% (95% CI: 0.9, 11.5) in 73 patients with a low or negative PD-L1 score.”

The most common adverse reactions experienced by patients while taking Imfinzi include:

The application, which was granted accelerated approval, priority review, and Breakthrough Therapy Designation, was approved six weeks prior to the FDA’s goal date. In its announcement, FDA states that “as a condition of the accelerated approval, AstraZeneca is required to complete an ongoing clinical trial to confirm clinical benefit of durvalumab.”

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